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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus CS Acute Care" Troponin I (cTnI) TestPak

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  Class 2 Device Recall Stratus CS Acute Care" Troponin I (cTnI) TestPak see related information
Date Initiated by Firm May 29, 2019
Create Date July 30, 2019
Recall Status1 Terminated 3 on May 12, 2022
Recall Number Z-2135-2019
Recall Event ID 82990
510(K)Number K051650  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Stratus CS Acute Care cTNI TestPak, SMN 10445071

Product Usage:
In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
Code Information Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact
781-269-3000
Manufacturer Reason
for Recall		 Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 29, 2019, Siemens issued Urgent Medical Device Correction notices to U.S.A. customers via FedEx courier service and Urgent Field Safety Notices to international customers via email. Actions to be Taken by the Customer: 1. Do not use TestPaks within 2 mos of expiration. 2. Repeat samples with cTNL results above 0.07 ng/mL or your institution's established 99th percentile value. 3. Complete and return the Field Correction Effectiveness Check form 4. Retain a copy of the letter with your laboratory records and forward a copy of the notice to anyone to whom you may have distributed the product. Siemens is working to resolve this issue and will contact customers when additional information is available. Siemens will reimburse users for repeat tests and discarded cTNL TestPaks within 2 months of the printed expiration date associated with this field corrective action.
Quantity in Commerce 2312
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = DADE BEHRING, INC.
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